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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K171528
Device Name Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)
Applicant
Avantsonic Technology Co., Ltd.
No.394, Jingdongfang Avenue
Beibei District
Chongqing,  CN 400714
Applicant Contact Cuiling Wu
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
22A, Haijing Square
No. 18, Taizi Road
Nanshan District, Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received05/25/2017
Decision Date 01/24/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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